Dewmar International BMC Inc (DEWM)

[Det_Robert_Thorne]

Show me the FDA "Close Out" letter

FDA has been a non issue for a long time .

Moran's explanation in the 2014 annual report doesn't say that the FDA told him that it's okay to ship Lean as it was, but that he is interpreting the fact that DEWM has been shipping it without a "Cease" letter from the FDA is the equivalent of an "okay" from the FDA. That's why he continued the under-the-RADAR sales.

See page 28 for the "weasel words" description:

http://www.otcmarkets.com/financialReportViewer?symbol=DEWM&id=174239

DEWM's warning from the FDA was issued in April, 2014, so the following applies:

Warning Letter Close-Out Letter Program (applies to letters issued on or after Sept. 1, 2009)

FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

A close-out letter will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA. Usually, the standard for verifying that corrections have been implemented will be a follow-up inspection. If the Warning Letter contains violations that by their nature are not correctable, then no close-out letter will issue. Future FDA inspections and regulatory activities may further assess the adequacy and sustainability of these corrections. Should violations be observed during a subsequent inspection or through other means, enforcement action may be taken without further notice. The FDA office that issued the Warning Letter will issue the close-out letter, and that office may be contacted for information on a particular Warning Letter.

https://www.fda.gov/iceci/enforcementactions/warningletters/ucm278624.htm